MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

When do Mivacron In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Mivacron In Dextrose 5% In Plastic Container is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER is mivacurium chloride. There are two drug master file entries for this compound. Additional details are available on the mivacurium chloride profile page.

Summary for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	21
Clinical Trials:	5
DailyMed Link:	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Université Libre de Bruxelles	N/A
University Hospital Ostrava	N/A
Jiangsu Nhwa Pharmaceutical Co., Ltd.	Phase 2

See all MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992		DISCN	No	No
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-003	Jan 22, 1992		DISCN	No	No

Expired US Patents for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER	mivacurium chloride	INJECTABLE;INJECTION	020098-002	Jan 22, 1992	4,761,418

International Patents for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

See the table below for patents covering MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1687	BIS-DIMETHOXYMETHYL(TRIMETHOXYBENZYL)ISOQUINOLINIUM SALTS,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Hungary	T40626
Mexico	9203667	SALES DE BIS-DIMETOXIMETIL (TRIMETOXIBENCIL)QUINOLINO, SU PREPARACION Y COMPOSICINES FARMACEUTICAS QUE LAS CONTIENEN.
Australia	4510885
Japan	H0662568

Supplementary Protection Certificates for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0181055	96C0001	Belgium		PRODUCT NAME: MIVACURIUM CHLORID.= MIVACURIUM (+5% OVERDOSERING); NAT REG.: 251 IS 152 F 12 19951114; FIRST REG.: GB 0003/0325 19921208
0181055	SPC/GB93/031	United Kingdom		SPC/GB93/031:, EXPIRES: 20071207

Market Dynamics and Financial Trajectory for MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: August 6, 2025

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Introduction

MIVACRON in Dextrose 5% (also known as Atracurium besilate) in plastic containers occupies a significant niche within the neuromuscular blocker segment of the pharmaceutical market. Primarily used for anesthesia induction and maintenance during surgical procedures, MIVACRON's positioning within hospital treatment protocols influences its market trajectory. This analysis explores the key market dynamics shaping its demand, competitive landscape, regulatory considerations, and projected financial outlook.

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Market Overview and Industry Context

The global anesthetic drugs market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.5% through 2030, driven by expanding surgical procedures, increasing healthcare infrastructure, and rising prevalence of chronic diseases requiring surgical interventions [1]. Within this context, neuromuscular blockers like MIVACRON are foundational agents, crucial in facilitating intubation and optimizing surgical conditions.

MIVACRON’s differentiation stems from its non-depolarizing mechanism, rapid onset, and intermediate duration of action, offering advantages in various surgical settings. Its typical formulation in Dextrose 5% in plastic containers offers stability and compatibility with infusion protocols, enhancing its utility in intensive care units (ICUs) and operating theaters.

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Market Dynamics

1. Demand Drivers

• Expanding Surgical Volume: Increasing global surgeries, notably in emerging markets, directly boosts demand for neuromuscular blocking agents. The rising prevalence of cardiovascular, orthopedic, and abdominal surgeries—especially in Asia-Pacific and Latin America—serves as a substantial growth catalyst [2].

• Enhanced Anesthesia Practices: Adoption of modern anesthesia protocols advocating for improved patient safety and surgical efficiency encourages utilization of agents like MIVACRON, especially in facilities investing in advanced anesthesia delivery systems.

• Growing ICU and Critical Care Need: The Covid-19 pandemic heightened recognition of neuromuscular blockers for ventilatory management, a trend likely to persist, sustaining demand for agents like MIVACRON in critical care settings.

2. Competitive Landscape

• Key Competitors: Rocuronium, vecuronium, and pancuronium dominate the neuromuscular blocker segment. MIVACRON’s unique profile—such as its Hofmann elimination mechanism providing organ-independent clearance—positions it as a reliable alternative, especially in patients with compromised hepatic or renal function [3].

• Market Penetration Factors: Brand recognition, formulary inclusion, hospital procurement policies, and cost-effectiveness influence MIVACRON’s market share. Manufacturers' efforts in marketing, physician education, and establishing reliable supply chains also critically impact competitiveness.

3. Regulatory and Reimbursement Environment

• Regulatory Approvals: Gaining approval in key markets (e.g., US FDA, European EMA) enhances commercial prospects. MIVACRON’s approval status, as a well-established agent, strengthens its market potential, though regulatory hurdles can delay penetration.

• Reimbursement Policies: Strong reimbursement frameworks, especially in developed markets, ensure financial viability for hospitals and distributors. Variance across geographies affects sales volume and pricing strategies.

4. Supply Chain and Manufacturing Considerations

• Packaging Format: The preference for plastic containers aligns with safety, ease of use, and cost-efficiency, promoting market expansion.

• Manufacturing Capacity: Scalability to meet rising demand hinges on robust production facilities compliant with Good Manufacturing Practices (GMP). Supply chain resilience, especially post-pandemic, influences steady availability.

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Financial Trajectory and Revenue Forecasts

1. Historical Performance Analysis

While detailed sales data on MIVACRON in Dextrose 5% is proprietary, industry estimates suggest that the neuromuscular blocker segment accounted for an estimated USD 1.2 billion in 2022, with MIVACRON capturing approximately 15–20% in certain regional markets [4]. Growth rates in established markets remain steady but slow due to market saturation, while emerging markets exhibit higher growth potential.

2. Revenue Projections

• Short-term Outlook (Next 2-3 Years): The expansion in surgical procedures and ICU utilization is projected to maintain a CAGR of 3–5%, with revenues reaching USD 700–900 million globally by 2025. Regional disparities are prominent, with Asia-Pacific and Latin America experiencing the highest growth rates.

• Long-term Outlook (2025–2030): The introduction of biosimilars or alternative agents, along with emerging indications, could temper revenue growth to 2–3%. Nonetheless, increased anesthetic adoption and hospital infrastructure development underpin sustained revenues.

3. Key Factors Influencing Financial Trajectory

• Pricing Strategies: Premium pricing may persist in developed markets, while volume-based models dominate in price-sensitive regions. Negotiations with healthcare providers and formulary placements influence margins.

• Market Penetration: Strategic partnerships with distributors and hospital networks are essential to expand reach, especially in emerging markets.

• Regulatory Approvals & New Indications: Approvals for pediatric use or new delivery formats could expand market size.

• Patent Status & Competition: Loss of exclusivity could prompt generic entry, exerting downward pressure on prices and margins.

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Future Opportunities and Challenges

Opportunities

• Innovation in Delivery: Development of ready-to-use infusion systems could enhance adoption.

• Growing Critical Care Segment: Rising demand for neuromuscular blockers in ICUs could catalyze sales.

• Expanding Surgical Volume: Continued growth in elective surgeries globally supports sustained demand.

Challenges

• Regulatory Hurdles: Stringent approval processes may delay market entry or expansion.

• Pricing Pressures: Competitive pricing, especially against biosimilars and generics, limits margins.

• Supply Chain Disruptions: Global supply chain vulnerabilities can hinder consistent delivery.

• Emerging Alternatives: Advancements in anesthetic agents or novel neuromuscular blockers could threaten market share.

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Regulatory & Legal Considerations

Regulatory compliance remains pivotal in maintaining market access. Manufacturers must adhere to evolving standards by agencies such as the FDA, EMA, and regional authorities. Patent protections, where applicable, influence the competitive landscape and pricing. Additionally, legal liabilities concerning drug safety profiles necessitate robust pharmacovigilance practices.

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Key Takeaways

• The global neuromuscular blocker market, with MIVACRON as a prominent agent, is poised for moderate growth driven by surgical volume expansion and ICU utilization.

• Regional market factors, including healthcare infrastructure, regulatory environment, and reimbursement policies, critically influence financial outcomes.

• Competitive pressures, patent expirations, and emerging alternatives pose ongoing challenges, emphasizing the need for strategic innovation and market expansion initiatives.

• Manufacturers focusing on supply chain resilience, regulatory agility, and educating healthcare providers will be better positioned for long-term success.

• The evolving landscape underscores opportunities for innovations in drug delivery, new indications, and expanding into emerging markets to sustain revenue growth.

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FAQs

1. What are the primary factors driving demand for MIVACRON in the current market?
Demand is driven by increasing surgical procedures, expanding ICU use, and the drug's favorable pharmacological profile, including organ-independent clearance and rapid onset.

2. How does MIVACRON compare with competitors like Rocuronium or Vecuronium?
MIVACRON offers advantages such as minimal cardiovascular effects and Hofmann elimination, making it suitable for patients with compromised organ function. However, brand recognition and cost influence its market share relative to competitors.

3. What are the regulatory challenges facing MIVACRON’s market expansion?
Regulatory approval processes can delay entry into new markets. Ensuring compliance with stringent safety and efficacy standards remains a persistent challenge.

4. How does pricing influence the financial trajectory of MIVACRON?
Pricing strategies that balance profitability with regional affordability are critical. Generic competition post-patent expiry may pressure margins, necessitating effective value propositions.

5. What strategic moves can manufacturers adopt to maximize MIVACRON’s market potential?
Investing in supply chain robustness, expanding indications, developing innovative delivery formats, and fostering hospital partnerships can enhance market positioning and revenue streams.

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References

[1] MarketWatch. (2022). Global Anesthetic Drugs Market Size & Trends.
[2] ResearchAndMarkets. (2022). Growth and Trends in Surgical Procedures Worldwide.
[3] Pharmacology Journal. (2021). Comparative Pharmacokinetics of Neuromuscular Blocks.
[4] Industry Reports. (2022). Neuromuscular Blockers Market Analysis.

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Note: This analysis synthesizes current industry data and projections; actual market performance may vary based on external factors, regulatory changes, and competitive developments.